Design of a non sterile Oral Solid Dosage Area

[bsg]

I find in number of Multinational Pharma house a Design of Class 100,000 and even 10,000 Clean Rooms in normal Oral Solid Dosage preparation areas.It is not clear to me how the system with HEPA can operate in Dusty environment of OSD.Is there any international guideline which specifies any cleanliness level for non sterile OSD Operation?

In Indian GMP no such clenliness level is prescribed for non sterile area.A combination of course and fine filter ( maybe EU-4/EU-6) is enough.

I would also like to know whether any such International guide exists for other non sterile operations like External Preparation etc.

Sengupta, Jayneil Technologies Pvt.Ltd.

 

[G1DESIGN]

most areas use eu8 primary filtration to filter large particulat and then this iss fed to terminal eu 14 grade
filter to provide the class 10000 standard

 

[bsg]

Dear G1DESIGN,

Thanks for the reply.My question was whether any written guideline exists for cleanliness Class/level for non sterile Production ( say OSD)

If GMP requirement in any guidelines ( WHO/FDA/TGA/EU etc) does not exist why should one go for 10,000 or for arguments sake 100,000 areas for non sterile production activity?
bsg

Sengupta, Jayneil Technologies Pvt.Ltd.

 

[G1DESIGN]

sorry have you tried the ISPE sit theres a forum section in there that deals with this kind of thing

i design downflow booths and isolators for a couple of companies and yes there are guidelines and documentation especially for this kinfd of question on monday when i get back to work ill dig them out and get the doc numbers for you